SPARK- a Digital Platform to Improve Self-management of Gestational Diabetes
- Conditions
- Gestational Diabetes Mellitus
- Interventions
- Behavioral: SPARK
- Registration Number
- NCT05348863
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
Gestational diabetes mellitus (GDM) is an increasing public health challenge. Innovative, effective and scalable lifestyle interventions to support women with GDM to manage their disease and to prevent adverse obstetric and neonatal outcomes as well as later morbidity are requested.The aim of this project is to evaluate whether a novel, mobile health (mHealth) platform (SPARK) can improve self-management of GDM and prevent adverse maternal and offspring outcomes. SPARK is a multi-centre randomised controlled trial recruiting women diagnosed with GDM in South Eastern Sweden. Women will be randomised to the control or intervention group. All women will receive standard care. The intervention group will also receive support through the SPARK platform for healthy eating, physical activity and glycaemic control. Pregnancy outcomes are glycaemic control (primary), diet, physical activity, metabolic and inflammatory biomarkers in gestational week 36-37 as well as adverse obstetric and neonatal outcomes. Secondary outcomes also include cardiometabolic risk, physical activity and healthy eating behaviours one-year postpartum.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 360
- a confirmed diagnosis of GDM detected by oral glucose tolerance test in accordance with the World Health Organization guidelines
- known pre-pregnancy diabetes
- twin pregnancy
- <18 years of age
- severe co-morbidities that would limit participation or a previously diagnosed severe psychiatric illness.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SPARK app SPARK Access to the SPARK app which will provide support for a healthier diet and increased physical activity as well as daily monitoring of blood glucose levels.
- Primary Outcome Measures
Name Time Method Glucose control At the end of the intervention in gestational weeks 36-37 Time in Range percent of time for glucose levels within clinical target levels using continous glucose monitoring
HbA1c At the end of the intervention in gestational weeks 36-37 Glycosylated hemoglobulin
- Secondary Outcome Measures
Name Time Method Diet intake quality using three dietary recalls by means of the Riksmaten Flex method One year post partum Diet intake quality will be assessed using three 24 hour dietary recalls by means of the Riksmaten Flex web-based dietary recall method.
Gestational weight gain From pre-prepregnancy up to 40 weeks of gestation Increase in body weight during pregnancy
Physical activity using accelerometry One year post partum Time spent on physical activity at different levels (sedentary, light, moderate, vigorous)
Incidence of pre-eclampsia Up to delivery Diagnosis of pre-eclampsia
Incidence of Caesarean sections Up to delivery Delivery by caesarean sections
Incidence of pregnancy induced hypertension Up to delivery Diagnosis of pregnancy induced hypertension
Metformin/insulin treatment Up to delivery Introduction of metformin/insulin treatment
Preterm birth Up to delivery Delivery before 37 completed weeks
Infant birth weight At birth Infant birth weight in grams
Infant birth length At birth Infant birth length in centimetres
Infant Apgar score At birth Infant Apgar score at 1, 5 and 10 min
Incidence of large-for gestational-age infant At birth Birth weight \>90th percentile for gestational age and gender
Infant shoulder dystocia At birth Incidence of infant shoulder dystocia
Infant hypoglycaemia At birth Incidence of infant hypoglycaemia
Glucose control From inclusion (baseline) to end of intervention in gestational week 36-37 Adherence to protocol for daily glucose monitoring (four times per day)
Glycaemic variability I At the end of the intervention in gestational week 36-37 Coefficient of variation for glucose excursion over 24 hrs using continous glucose monitoring
Glycaemic variability II At the end of the intervention in gestational week 36-37 Mean for glucose excursion over 24 hrs using continous glucose monitoring
Delivery complications At delivery Induction of delivery (yes or no), vacuum extraction (yes or no, epidural anesthesia (yes or no)
Hospital stay The first week post partum Hospital stay (duration from admission of delivery to discharge) including neonatal care
Glucose- insulin treatment during delivery During delivery Incidence of glucose- insulin treatment during delivery
Metabolic and inflammatory biomarkers I At gestational weeks 36-37 Maternal levels of Insulin-like Growth Factor I in serum
Metabolic and inflammatory biomarkers II At gestational weeks 36-37 Maternal levels of Insulin-like Growth Factor I binding proteins in serum
Metabolic and inflammatory biomarkers III At gestational week 36-37 Maternal levels of copeptin in serum
Metabolic and inflammatory biomarkers IV At gestational week 36-37 Maternal levels of leptin in serum
Metabolic and inflammatory biomarkers V At gestational week 36-37 Maternal levels of midregion pro-adrenomedullin (MR-proANP) in serum
Maternal cardiometabolic risk profile One year post partum A maternal cardiometabolic risk profile score one year post partum will be calculated using information on triglycerides and high-density cholesterol in serum, waist circumference, blood glucose as well as the systolic and diastolic blood pressure.
Metabolic and inflammatory biomarkers VI At gestational week 36-37 Maternal levels of midregion pro-atrial natriuretic peptide (MR-proADM) in serum
Glycaemic variability III Full intervention period (up to 3 months) Glucose levels using glucose meter (capillary sampling)
Microvascular function I One year post partum Oxygen saturation using PeriFlux6000 Enhanced Perfusion and Oxygen Saturation
Microvascular function II One year post partum Total speed perfusion using PeriFlux6000 Enhanced Perfusion and Oxygen Saturation
Trial Locations
- Locations (1)
Maternity health care, Region Östergötland
🇸🇪Linköping, Sweden